Pharmacist, Quality Oversight and Compliance

About the role

The Pharmacist, Quality Oversight & Compliance will serve as the primary point of contact at the site for complaint management and adverse events related to compounded products and products obtained from third party suppliers/pharmacy partners. The role will be onsite and will report to the pharmacist in charge, and will ensure that complaints are thoroughly reviewed, investigated and reported according to applicable state rules and regulations as well as Federal rules and regulations.

Responsibilities

• Assist in product quality complaints evaluation to determine if it may be an Adverse Drug Event or an Adverse Drug Effect
• Ensure product quality complaints are thoroughly investigated, documented, and communicated in a timely and transparent manner to customers and relevant stakeholders
• Evaluate product quality complaints, Adverse Drug Events and Adverse Drug Effects to determine reporting requirements
• Report to appropriate BOP / Agency
• Report to appropriate team as required
• Assist with product quality complaint investigations, and be a key person to retrieve records from PMS, batch records, cleaning records, as applicable to the investigation
• Support return of products to the pharmacy, and assist with investigation and disposal
• Support data collection and trending of complaints and medical escalations to enhance customer experience and determine potential continuous Improvement opportunities
• Work closely with pharmacists onsite to ensure proper handling of complaints and Medical Escalations
• Collaborate on the development and review of SOPs and relevant training

Requirements

• Doctor of Pharmacy Degree (Pharm.D)
• Active pharmacist license in the state where the practice site is located
• Experience in a compounding pharmacy (503A or 503B)
• Experience in quality assurance roles in a regulated industry such as pharmaceuticals or compounding facilities
• Knowledge of state and federal pharmacy laws, rules and regulations and reporting requirements
• Experience with customer-facing interactions and the ability to maintain a positive and professional relationship with customers

Qualifications

• Effective knowledge of state and federal pharmacy laws, rules and regulations and reporting requirements
• Proficiency in standards including, USP 795, 797, and 800
• Business proficiency in English speaking, presenting, and writing with the ability to engage stakeholders at all levels of the organization and communicate complex issues clearly and concisely
• Track record of successfully resolving complex issues with structured problem solving approaches
• Experience managing multiple projects, and tasks simultaneously with effective coordination
• Demonstrated ability to deliver on-time results
• Excellent analytical skills with the ability to identify trends, perform root cause analysis, and implement corrective actions
• Willingness to work in a team environment and promote company culture
• Knowledge of customer experience management and the role complaints play in customer retention

Skills

• Hands-on, detail-oriented and highly organized individual
• Strong background in pharmaceutical and/or pharmacy customer complaint management, medical escalations/adverse events, and trending of PMS related customer data
• Experience with Google Suite
• Working experience in EMR, Zendesk, pharmacy management system and other complaint management software

Benefits

• Competitive salary & equity compensation for full-time roles
• Unlimited PTO, company holidays, and quarterly mental health days
• Comprehensive health benefits including medical, dental & vision, and parental leave
• Employee Stock Purchase Program (ESPP)
• 401k benefits with employer matching contribution
• Offsite team retreats